N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21.
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome
(ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, Bernard GR, Thompson
BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL.
Department of Pulmonary, Allergy, and Critical Care Medicine, Cleveland Clinic,
9500 Euclid Ave., Desk A-90, Cleveland, OH 44195, USA. wiedemh@ccf.org
BACKGROUND: Optimal fluid management in patients with acute lung injury is
unknown. Diuresis or fluid restriction may improve lung function but could
jeopardize extrapulmonary-organ perfusion. METHODS: In a randomized study, we
compared a conservative and a liberal strategy of fluid management using explicit
protocols applied for seven days in 1000 patients with acute lung injury. The
primary end point was death at 60 days. Secondary end points included the number
of ventilator-free days and organ-failure-free days and measures of lung
physiology. RESULTS: The rate of death at 60 days was 25.5 percent in the
conservative-strategy group and 28.4 percent in the liberal-strategy group
(P=0.30; 95 percent confidence interval for the difference, -2.6 to 8.4 percent).
The mean (+/-SE) cumulative fluid balance during the first seven days was
-136+/-491 ml in the conservative-strategy group and 6992+/-502 ml in the
liberal-strategy group (P<0.001). As compared with the liberal strategy, the
conservative strategy improved the oxygenation index ([mean airway pressure x the
ratio of the fraction of inspired oxygen to the partial pressure of arterial
oxygen]x100) and the lung injury score and increased the number of
ventilator-free days (14.6+/-0.5 vs. 12.1+/-0.5, P<0.001) and days not spent in
the intensive care unit (13.4+/-0.4 vs. 11.2+/-0.4, P<0.001) during the first 28
days but did not increase the incidence or prevalence of shock during the study
or the use of dialysis during the first 60 days (10 percent vs. 14 percent,
P=0.06). CONCLUSIONS: Although there was no significant difference in the primary
outcome of 60-day mortality, the conservative strategy of fluid management
improved lung function and shortened the duration of mechanical ventilation and
intensive care without increasing nonpulmonary-organ failures. These results
support the use of a conservative strategy of fluid management in patients with
acute lung injury. (ClinicalTrials.gov number, NCT00281268
[ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.